The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone or in combination with drug therapies and surgery to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life.
Implantable medical devices are commonly used today to treat patients suffering from various ailments. Implantable medical devices can be used to treat any number of conditions such as pain, incontinence, movement disorders such as epilepsy and Parkinson's disease, and sleep apnea. Additionally, use of implantable medical devices appears promising to treat a variety of physiological, psychological, and emotional conditions.
One type of implantable medical device is an Implantable Neuro Stimulator (INS). The INS is implanted at a predetermined location in the patient's body. The INS generates and delivers mild electrical impulses to neurostimulation areas in the body using an electrical lead. The INS electrical stimulation signals at neurostimulation sites or areas influence desired neural tissue, tissue areas, nervous system and organs to treat the ailment of concern. The stimulation sites can also include the spinal cord, brain, body muscles, peripheral nerves or any other site selected by a physician. For example, in the case of pain, electrical impulses may be directed to cover the specific sites where the patient is feeling pain. Neurostimulation can give patients effective pain relief and can reduce or eliminate the need for repeat surgeries and the need for pain medications.
In the case of an INS, the system generally includes an implantable neuro stimulator (INS) (also known as an implantable pulse generator (IPG)), an external physician or clinician programmer, a patient programmer and at least one electrical lead. An INS is typically implanted near the abdomen of the patient, or other stimulation area as required. The lead is a small medical wire with special insulation and contains a set of electrodes (small electrical contacts) through which electrical stimulation is delivered. The INS can be powered by an internal source such as a rechargeable or non-rechargeable battery or by an external source such as a radio frequency transmitter. The INS contains electronics to generate and send precise, electrical pulses to the stimulation area to provide the desired treatment therapy. The clinician programmer is an external device that allows the physician or clinician to create and store preset stimulation therapy to be delivered by the INS. The clinician programmer communicates with the INS using radio waves, for example via telemetry. The patient programmer is an external hand-held device that allows the patient to optimize the stimulation therapy delivered by the INS. The patient programmer also communicates with the INS using radio waves, such as telemetry.
In existing INS devices, a clinician typically creates and stores preset patient therapy programs that are executed by the INS to deliver therapy to the patient. The preset patient therapy programs include specific therapy parameters that are set and created by a clinicians based on industry or clinician preferences, patient feedback, a patient's test results, or a combination of all of the above. The patient therapy programs are then downloaded into INS memory using the clinician programmer. The patient therapy programs then reside in both clinician programmer memory and INS memory. The stored preset patient therapy programs, which include specific therapy parameters, will allow the INS to generate the appropriate electrical stimulation signals for the patient's specific needs. The stored patient therapy programs contain parameters, including for example, electrode settings, signal intensity or strength (amplitude), the signal duration (pulse width), and the signal timing and cycling (pulse frequency or rate).
In addition, the electrodes associated with a medical device, such as an INS, may be arranged in a predetermined physical array or layout configuration at the stimulation site in the patient. In such a case, certain preset therapy parameters in the stored patient therapy programs will allow the INS to generate electrical stimulation signals at the electrodes in a particular directional sequence and physical direction, relative to their physical placement in the patient's body.
At present, patients do not have the ability to select and assemble the preset therapy programs, which were created by the clinician, or to create his/her own personalized therapy programs. A patient can typically access the stored preset clinician therapy programs but cannot create personalized therapy programs himself/herself. A patient must use and live with the preset therapy programs that have been created by the clinician. Moreover, the stimulation areas targeted by the INS's electrical leads on a patient's body are usually situated to alleviate or address pain or discomfort due to one body position or activity, e.g., sitting compared to walking, jogging or running. As a result, the combination of specifically situated stimulation areas and unchangeable clinician created preset therapy programs can lead to discomfort when a patient engages in activities that were not accounted for or foreseen by the clinician. The inability to modify the stored therapy programs can thus limit the activities that a patient may wish to engage in.
For the foregoing reasons there is a need for an apparatus and method that will allow patients to access stored preset clinician therapy programs so that the patient can create new personalized therapy programs that will enable the patient to participate in a variety of activities without undue discomfort or the need to visit a clinician for additional preset therapy programs.
It is an objective of the present invention to provide an apparatus and method to give patients the ability to assemble, label and store their own personalized therapy programs, on demand, from among the preset clinician therapy programs that are resident in INS memory.
It is an objective of the present invention to provide an apparatus and method to give patients more control to create personalized therapy programs and settings to fit their unique lifestyles thereby increasing patient satisfaction.